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Company Contact Info
- Kendall, FL
- Phone: 813-506-5420
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3rd shift QA Inspector
The Staffing Resource Group, Inc • Kendall, FL
Posted 5 days ago
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3rd shift QA Inspector
Full-time direct hire opportunity with a large pharmaceutical company!
Tuesday- Saturday; 10PM- 6:30 AM
- Inspect inbound components for manufacturing / packaging activity.
- Enforce cGMP compliance of manufacturing and packaging staff.
- Review and release Labels assuring compliance with quality specifications.
- Ensure that manufacturing and packaged products meet quality and customer standards and guidelines.
- Review in process and completed batch records and shipment paperwork for accuracy, completeness and adherence to cGMP.
- Assist in conducting site cGMP training.
- Review and update Standard Operating Procedures, track quality investigations, process deviations and follow up to ensure corrective actions are taken.
- Carry out duties in compliance with all state and federal regulations and guidelines, including FDA, specifically 21 CFR 111, 211 and 117.
- Ensure compliance of Manufactured/ Packaged product to FDA and regulatory standards.
- Monitor manufacturing / packaging process throughout its entirety.
- Review and disposition of nonconformance product.
- Assist Sanitation Supervisor on the overseeing of allergen program.
- Perform ATP Swabs on equipment after allergens.
QA Documentation Supervisor
- Minimum 3 years experience within an FDA environment
- Ability to deal confidently and effectively with all levels of employees to express ideas concisely and in an orderly, disciplined manner – both written and orally.
- Good understanding of cGMP and FDA regulations, specifically 21 CFR 111, 211 and 117.
- Driven, Organized; detail oriented.
- Able to effectively communicate in English written and oral.
- Able to prioritize multiple work assignments.
- Must be able to stand their ground and act in the interest of quality
- Able to see colors.
- Able to follow routine verbal and/or written instructions.
- Able to work under pressure and meet deadlines.